Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Management of dental pain emergencies is a challenge for the clinician, particularly when pain is due to endodontic infection.

Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior alveolar nerve block for mandibular molars anesthesia.

The aim of the study is the evaluation of Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.

Condition or disease	Intervention/treatment	Phase
Dental Pain	Procedure: Dental anesthesia	Not Applicable

Detailed Description:

Management of dental pain emergencies is a challenge for the clinician, particularly when pain is due to endodontic infection. Failure rate of local anesthesia highly increases with irreversible pulpitis or inflamed periradicular tissue.

Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior alveolar nerve block for mandibular molars anesthesia (from teeth 35 up to 38 and from 45 up to 48).

The primary aim of the study is the evaluation of Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.

Four clinical situations are evaluated : pulpitis; periapical abcess; pulpal hyperemia; asymptomatic decayed tooth.

Evaluated parameters are : speed of sedation, ability of cure, additional anesthesia needed, total of needles and cartridges used, side effects. Time and validation of complete anesthesia is controlled by pulp tester.

Studied population is patients cared in restorative, endodontics department.

Pulpal and periapical molar and premolar sedation is randomly managed by inferior alveolar nerve block or Quicksleeper intraosseous anesthesia, among studied population (divided in 2 groups of 50 patients). Pulp-tester measures anesthesia minute by minute.

The comparison of study results to bibliography, guidelines and advantages for using mechanical Quicksleeper anesthesia system will be discussed.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	37 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block
Study Start Date :	October 2009
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	September 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Quicksleeper intraosseous anesthesia; Pulpal and periapical molar and premolar sedation is managed by Quicksleeper intraosseous anesthesia.	Procedure: Dental anesthesia; Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.
Active Comparator: Inferior alveolar nerve block; Pulpal and periapical molar and premolar sedation is managed by inferior alveolar nerve block.	Procedure: Dental anesthesia; Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. To evaluate the Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment. [ Time Frame: 2 years ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Irreversible pulpitis on second mandibular premolar or mandibular molars
• Necessity of pulpotomy or pulpectomy

Exclusion Criteria:

• Pregnancy, chest feeding
• Non dental emergency state
• hypersensibility to local anesthesia
• Pheochromocytoma
• Irregularity of cardiac rhythm
• Myocardial infarct in the 6 previous months
• Hepatic porphyria

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Assistance Publique - Hôpitaux de Marseille
Marseille, France

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Principal Investigator:	Herve TASSERY	Assistance Publique-Hôpitaux de Marseille

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT01177423 History of Changes
Other Study ID Numbers:	2009-08; 2009-A00684-53
First Posted:	August 9, 2010
Last Update Posted:	August 29, 2014
Last Verified:	August 2014

Keywords provided by Assistance Publique Hopitaux De Marseille:

restorative odontology; Patients cared in restorative odontology department

Additional relevant MeSH terms:

Toothache; Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations	Nervous System Diseases; Signs and Symptoms; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs